1- Determining and comparing the frequency distribution of laparoscopic surgery to open surgery
2- Determining and comparing the average amount of intraoperative bleeding
3- Determining and comparing the frequency distribution of bile leak from the drain after surgery
4- Determining and comparing the average duration of surgery
5- Determining and comparing the frequency distribution of visceral and bile duct damage during and after surgery
6- Determining and comparing the frequency distribution of the need for ERCP reoperation after surgery
7- Determining and comparing the frequency distribution of infection at the site of postoperative surgery
8- Determining and comparing the average duration of postoperative hospitalization
Design
A randomized, single blind, randomized, clinical trial on 188 patients. For randomization, the method of 2 random blocks is used.
Settings and conduct
Interventional study, randomized clinical trial and single blind,Applied approach in Isfahan medicinal teaching hospitals
Participants/Inclusion and exclusion criteria
Entry requirement:
Patients over 18 years old with cholecholithiasis who are candidates for ERCP and then cholecystectomy
No entry conditions:
1. Intolerance to general anesthesia
2. Severe liver and kidney dysfunction
3. Patients who refuse surgery
4. Occurrence of pancreatitis after performing ERCP
Intervention groups
Patients are divided into two groups after ERCP and in one group early cholecystectomy is performed and in the other group delayed cholecystectomy is performed
Main outcome variables
Local infection; duration of surgery; bleeding during surgery; conversion to open surgery; bile leakage from drain after surgery; damage to viscera and bile ducts during surgery; need for ERCP again after surgery; duration Hospitalization after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201013049017N3
Registration date:2022-10-12, 1401/07/20
Registration timing:registered_while_recruiting
Last update:2022-10-12, 1401/07/20
Update count:0
Registration date
2022-10-12, 1401/07/20
Registrant information
Name
Hamid Talebzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 1995
Email address
talebzadeh.h@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the outcomes of early cholecystectomy compared to delayed cholecystectomy after ERCP
Public title
Evaluation of the time of cholecystectomy after ERCP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with coledocolitiasis who are candidates for ERCP and then cholecystectomy
Exclusion criteria:
Intolerance to general anesthesia
Severe liver and kidney dysfunction
Patients who refuse surgery
Occurrence of pancreatitis after ERCP
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling, the method of double random blocks with SPSS software is used. In this way, two people who come for surgery are considered as one block until the number of blocks reaches 94. Then one person from each block is randomly assigned by the early method and one person by the delayed method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are randomly assigned to receive one type of intervention, and only researchers know which participants are in which group, but participants do not know
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Sofeh Blvd,Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2022-03-08, 1400/12/17
Ethics committee reference number
IR.MUI.MED.REC.1400.835
Health conditions studied
1
Description of health condition studied
Cholecystitis,Choldocolithiasis
ICD-10 code
K80.5
ICD-10 code description
Calculus of bile duct without cholangitis or cholecystitis
Primary outcomes
1
Description
Local infection
Timepoint
7 days after surgery
Method of measurement
File Reading and Physical Examination
2
Description
Duration of surgery
Timepoint
During surgery
Method of measurement
File Reading
3
Description
Bleeding during surgery
Timepoint
During surgery
Method of measurement
File Reading
4
Description
Conversion to open surgery
Timepoint
During Surgery
Method of measurement
File reading
5
Description
Bile leakage from the drain
Timepoint
one day after the surgery
Method of measurement
File Reading
6
Description
Damage to internal organs and bile ducts
Timepoint
During surgery
Method of measurement
File reading
7
Description
Need for repeat ERCP
Timepoint
7 days after surgery
Method of measurement
File Reading and Physical Examination
8
Description
Duration of hospitalization
Timepoint
7 days after surgery
Method of measurement
File reading
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: early cholecystectomy - in this group, the time interval between ERCP and cholecystectomy is less than 6 days. All patients are NPO 6 hours before the operation. Vital signs, heart monitoring and routine tests will be done for all patients.Laparoscopic cholecystectomy operation will be performed as 4 ports (subxiphoid, preumbilical ports with 10 mm incisions, midclavicular and anterior axillary ports with 5 mm incisions). The rate of conversion of laparoscopic surgery to open surgery, the amount of bleeding, the average duration of surgery, the amount of damage to viscera and bile ducts during the operation will be recorded. The average duration of hospitalization and the amount of bile leakage from the drain after surgery will be extracted from his file and recorded. The rate of need for repeat ERCP and the rate of infection at the surgical site after the operation will also be recorded through the follow-up of the patient's condition. After recording the extracted data and statistical analysis, the obtained results will be analyzed and written.
Category
Treatment - Surgery
2
Description
The second intervention group: late cholecystectomy - in this group, the time interval between ERCP and cholecystectomy is more than 6 days. All patients are NPO 6 hours before the operation. Vital signs, heart monitoring and routine tests will be done for all patients.Laparoscopic cholecystectomy operation will be performed as 4 ports (subxiphoid, preumbilical ports with 10 mm incisions, midclavicular and anterior axillary ports with 5 mm incisions). The rate of conversion of laparoscopic surgery to open surgery, the amount of bleeding, the average duration of surgery, the amount of damage to viscera and bile ducts during the operation will be recorded. The average duration of hospitalization and the amount of bile leakage from the drain after surgery will be extracted from his file and recorded. The rate of need for repeat ERCP and the rate of infection at the surgical site after the operation will also be recorded through the follow-up of the patient's condition. After recording the extracted data and statistical analysis, the obtained results will be analyzed and written.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
ََAmin Hospital
Full name of responsible person
Hamid Talebzadeh
Street address
ََEbn-e-Sina Ave, Amin Hospital
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
2
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Hamid Talebzadeh
Street address
Sofeh Blvd, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Hezarjerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Web page address
https://mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Talebzadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezarjerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Talebzadeh.h@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Talebzadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezarjerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Talebzadeh.h@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Talebzadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Hezar Jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 1995
Fax
Email
talebzadeh.h@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after deidentifying individuals
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
People who are engaged in the industry can apply for them.
Under which criteria data/document could be used
In all circumstances
From where data/document is obtainable
Internet networks
What processes are involved for a request to access data/document